Treatment Continuation Study for Patients With ALS/MND Who Completed Study CMD-2019-001

February 15, 2022 updated by: Collaborative Medicinal Development Pty Limited

A Treatment Continuation Study for Patients With Amyotrophic Lateral Sclerosis/Motor Neuron Disease Who Have Successfully Complete Study CMD-2019-001

Provides up to six months treatment with CuATSM for subjects who have successfully completed study CMD-2019-001

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Provides up to six months treatment with CuATSM for subjects who have successffulyl completed study CMD-2019-001. [This allows subjects randomized to placebo on study CMD-2019-001 to receive up to six months treatment with CuATSM and provides an up to an additional six months treatment with CuATSM for subjects randomized to CuATSM on study CMD-2019-001]

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Macquarie Park, New South Wales, Australia
        • Macquarie University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • signed informed consent prior to initiation of any study-specific procedures and treatment
  • documented completion of protocol-specified assessments following completion of 24 weeks treatment on study CMD-2019-002
  • Investigator considers patient has been tolerating treatment on study CMD-2019-001 and may benefit from continued treatment with CuATSM

Exclusion Criteria:

  • not dependent on mechanical ventilation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cu(II)ATSM
copper-containing synthetic small molecule
Drug: Cu(II)ATSM
cooper-containing synthetic small molecule
Other Names:
  • diacetylbis(N(4)-methylthiosemicarbazonato) copper(II)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment-related changes in disease severity
Time Frame: 24 weeks
Treatment-related changes in disease severity assessed by ALS Functional Rating Scale - Revised (ALSFRS-R)
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment-related changes in cognitive function
Time Frame: 24 weeks
Treatment-related changes in cognitive function by Edinburgh Cognitive and Behavioral Assessment (ECAS) score
24 weeks
Treatment-related changed in respiratory function
Time Frame: SVC
Treatment-related changes in respiratory function by seated slow vital capacity (SVC)
SVC
Treatment tolerance
Time Frame: 24 weeks
Treatment tolerance based on dose reductions and dose terminations due to adverse events
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborative Medicinal Development Pty Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 19, 2020

Primary Completion (ACTUAL)

November 18, 2021

Study Completion (ACTUAL)

February 15, 2022

Study Registration Dates

First Submitted

March 15, 2020

First Submitted That Met QC Criteria

March 15, 2020

First Posted (ACTUAL)

March 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 17, 2022

Last Update Submitted That Met QC Criteria

February 15, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMD-2020-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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